Thrombodyne Inc — Department of Health and Human Services SBIR Phase I: NIDCD

Description

ABSTRACTOtitis media or middle ear infections is a prevalent disease associated with early childhoodThe primary surgical intervention for persistent and recurring otitis media is insertion of ear tubestympanostomymyringotomy tubesThere are aboutear tubes placed annually in the United StatesA recognized risk with ear tubes is secondary infection or post operative otorrheaThe rate of secondary infections is as high asany time ear tubes are in placeAbsence of self protective properties either inherently or in concert with the host s immune system makes ear tubes prone to infectionRecurrent infections need to be addressed effectively and quickly as it can lead to hearing lossspeech defects and other developmental delays in childrenAntimicrobial technologies on ear tubes intended to address the above need have been commercialized in the pastThese include Medtronic s ActiventTM ear tubes with eluting silver technologies and OlympusPacificUltraSilTM which are passive technologiesThese antimicrobial ear tubes provide limited long term protection due to rapid depletion of active agents andor inactivation under biological milieuEar tubes being long term implants need better protection to prevent recurrent infectionsApplicants have developed a unique technology to reduce the risk of long term ear tube related infectionsThe proposed non depleting active technology will have broad spectrum efficacy without relying on release of active agent sThe goal of the proposed feasibility studies is to assess safety and antimicrobial performance of the novel ear tubes in appropriate preclinical modelsIn the first phase of the proposed evaluationdesign refinement and development is proposed to identify optimum parameters for the technology which will result in robust ear tube designIn the next stage of evaluationantimicrobial efficacyincluding broad spectrum activitywill be assessed on the lead design candidates in an in vitro model that simulates middle ear environmentReduction in microbial colonization on novel ear tubes will be reported relative to growth on an uncoated control ear tube and commercial antimicrobial ear tubesFinallysafety and biocompatibility of the lead design will be assessed in an animal modelchinchillasto ensure the tympanic membrane and other middle ear structures are not adversely affected by the presence of proposed technology on ear tubesAppropriate sample size and controlsuncoated ear tubes and commercially available antimicrobial ear tubewill be employed in the proposed studiesThe expected outcome of this proof of concept phase of the project will be to demonstrate adequate safety in vivo and antimicrobial efficacy of the new technology in vitroDemonstration of feasibility will set the stage for further commercial development of the technology NARRATIVE Ear tubes are placed in the ear drum to drain infected fluid from the middle earEar tube placements are one of the most common procedures performed in the United StatesHoweverthey are susceptible to secondary infections leading to recurrence of symptoms which may lead to hearing loss and speech defectsIn additionthe US healthcare system spends billions of dollars each year addressing this issueThe proposed commercialization project intends to study a unique approach to reduce ear tube infections and provide an effective solution for these patients and clinicians